Components:
Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 26.06.2023

Attention! Information on this page is intended only for medical professionals! Information is collected in open sources and may contain significant errors! Be careful and double-check all the information on this page!
Each 5-mg and 10-mg tablet contains Amlodipine (Telma AMH) besilate equivalent to Amlodipine (Telma AMH) 5 mg and 10 mg, respectively.
Amlodipine (Telma AMH) also contains the following excipients: Calcium hydrogen phosphate anhydrous, microcrystalline cellulose, magnesium stearate, sodium starch glycollate.
Amlodipine (Telma AMH) besilate is the besilate salt of Amlodipine (Telma AMH), a long-acting calcium-channel blocker. It is 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate. Its empirical formula is C20H25ClN2O5·C6H6O3S and has a molecular weight of 567.1.
Amlodipine (Telma AMH) besilate is a white crystalline powder and is slightly soluble in water and sparingly soluble in ethanol.
Each film-coated tablet contains losartan potassium 50 mg and Hydrochlorothiazide (Telma AMH) 12.5 mg.
Losartan potassium is 2-Butyl-4-chloro-1-[p-o-1H-tetrazol-5-yl-phenyl)benzyl]imidazole-5-methanol, potassium. Its empirical formula is C22H22ClKN6O and molecular weight is 461.
Hydrochlorothiazide (Telma AMH) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and molecular weight is 297.7.
Telmisartan (Telma AMH) is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as Telmisartan (Telma AMH) bind to the angiotensin II type 1 (AT1) receptors with high affinity, causing inhibition of the action of angiotensin II on vascular smooth muscle, ultimately leading to a reduction in arterial blood pressure. Recent studies suggest that Telmisartan (Telma AMH) may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.
Hypertension
Amlodipine (Telma AMH) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including Amlodipine (Telma AMH).
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine (Telma AMH) may be used alone or in combination with other antihypertensive agents.
Coronary Artery Disease (CAD)
Chronic Stable Angina
Amlodipine (Telma AMH) is indicated for the symptomatic treatment of chronic stable angina. Amlodipine (Telma AMH) may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina)
Amlodipine (Telma AMH) is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine (Telma AMH) may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD
In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, Amlodipine (Telma AMH) is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Hydrochlorothiazide (Telma AMH) (Hydrochlorothiazide (Telma AMH) capsule) is indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, Hydrochlorothiazide (Telma AMH) (Hydrochlorothiazide (Telma AMH) capsule) may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.
Usage in Pregnancy
The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia.
Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases a short course of diuretics may provide relief and may be appropriate.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.Hypertension
Telmisartan (Telma AMH) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
Cardiovascular Risk Reduction
Telmisartan (Telma AMH) is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.
High risk for cardiovascular events can be evidenced by a history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage. Telmisartan (Telma AMH) can be used in addition to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).
Studies of Telmisartan (Telma AMH) in this setting do not exclude the possibility that Telmisartan (Telma AMH) may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.
Use of Telmisartan (Telma AMH) with an ACE inhibitor is not recommended.
Amlodipine (Telma AMH) is used alone or together with other medicines to treat angina (chest pain) and high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Amlodipine (Telma AMH) is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. As a result, Amlodipine (Telma AMH) relaxes blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.
Amlodipine (Telma AMH) is available only with your doctor's prescription.
Hydrochlorothiazide (Telma AMH) is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.
Hydrochlorothiazide (Telma AMH) is also used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or treatment with a steroid or hormone medicine.
Hydrochlorothiazide (Telma AMH) is a thiazide diuretic (water pill). It is used to help reduce the amount of water in the body by increasing the flow of urine. It may also be used for other conditions as determined by your doctor.
This medicine is available only with your doctor's prescription.
Telmisartan (Telma AMH) is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.
Telmisartan (Telma AMH) is also used to lower the risk of heart attacks or stroke in patients 55 years of age and older who have diabetes or heart problems.
Telmisartan (Telma AMH) is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, Telmisartan (Telma AMH) relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Telmisartan (Telma AMH) is available only with your doctor's prescription.
Adults
The usual initial antihypertensive oral dose of Amlodipine (Telma AMH) is 5 mg once daily, and the maximum dose is 10 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine (Telma AMH) to other antihypertensive therapy.
Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.
Angina
The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.
Coronary Artery Disease
The recommended dose range for patients with coronary artery disease is 5–10 mg once daily. In clinical studies, the majority of patients required 10 mg.
Children
The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
How supplied
Dosage Forms And Strengths
Tablets
2.5 mg white, diamond, flat-faced, beveled edged, with "Amlodipine (Telma AMH)" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Amlodipine (Telma AMH)" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Amlodipine (Telma AMH)" on one side and "10" on the other
Storage And Handling
2.5 mg Tablets
Amlodipine (Telma AMH) – 2.5 mg Tablets (Amlodipine (Telma AMH) besylate equivalent to 2.5 mg of Amlodipine (Telma AMH) per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Amlodipine (Telma AMH)" on one side and "2.5" on the other side and supplied as follows:
NDC 0069-1520-68 Bottle of 90
5 mg Tablets
Amlodipine (Telma AMH) – 5 mg Tablets (Amlodipine (Telma AMH) besylate equivalent to 5 mg of Amlodipine (Telma AMH) per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Amlodipine (Telma AMH)" and "5" on one side and plain on the other side and supplied as follows:
NDC 0069-1530-68 Bottle of 90
NDC 0069-1530-41 Unit Dose package of 100
NDC 0069-1530-72 Bottle of 300
10 mg Tablets
Amlodipine (Telma AMH) – 10 mg Tablets (Amlodipine (Telma AMH) besylate equivalent to 10 mg of Amlodipine (Telma AMH) per tablet) are white, round, flat-faced, beveled edged engraved with both "Amlodipine (Telma AMH)" and "10" on one side and plain on the other side and supplied as follows:
NDC 0069-1540-68 Bottle of 90
NDC 0069-1540-41 Unit Dose package of 100
Storage
Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, lightresistant containers (USP).
Manufactured by: Pfizer, Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: March 2015
Usual Adult Dose of Hydrochlorothiazide (Telma AMH) for Edema:
Usual dose: 25 mg to 100 mg orally once or twice daily
Comments:
-Some patients respond to intermittent therapy, (i.e., administration on alternate days or on 3 to 5 days each week). Excessive response and undesirable electrolyte imbalance are less likely to occur with intermittent dosing.
Usual Adult Dose of Hydrochlorothiazide (Telma AMH) for Hypertension:
Initial dose: 25 mg orally once daily
Maintenance dose: May increase to 50 mg orally daily, as a single or 2 divided doses
Comments:
-Patients usually do not require doses in excess of 50 mg daily when used concomitantly with other antihypertensive agents.
Usual Adult Dose of Hydrochlorothiazide (Telma AMH) for Nephrocalcinosis:
Initial: 25 mg orally once daily
Maintenance dose: May increase to 50 mg twice daily
Usual Adult Dose of Hydrochlorothiazide (Telma AMH) for Osteoporosis:
Initial: 25 mg orally once daily
Maintenance dose: May increase to 50 mg daily
Usual Adult Dose of Hydrochlorothiazide (Telma AMH) for Diabetes Insipidus:
Initial: 50 mg orally once daily
Maintenance dose: May increase to 100 mg orally daily
Usual Pediatric Dose of Hydrochlorothiazide (Telma AMH) for Edema:
Less than 6 months: Up to 3 mg/kg/day (up to 1.5 mg/pound) orally in 2 divided doses
Less than 2 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 37.5 mg per day
2 to 12 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 100 mg per day
Usual Pediatric Dose for Hypertension:
Less than 6 months: Up to 3 mg/kg/day (up to 1.5 mg/pound) orally in 2 divided doses
Less than 2 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 37.5 mg per day
2 to 12 years: 1 to 2 mg/kg/day (0.5 to 1 mg/pound) orally daily as a single dose or in 2 divided doses
Maximum dose 100 mg per day
Hypertension
Dosage must be individualized. The usual starting dose of Telmisartan (Telma AMH) tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg.
Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Telmisartan (Telma AMH) is required, a diuretic may be added.
No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.
Telmisartan (Telma AMH) tablets may be administered with other antihypertensive agents.
Telmisartan (Telma AMH) tablets may be administered with or without food.
Cardiovascular Risk Reduction
The recommended dose of Telmisartan (Telma AMH) tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of Telmisartan (Telma AMH) are effective in reducing the risk of cardiovascular morbidity and mortality.
When initiating Telmisartan (Telma AMH) therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.
How supplied
Dosage Forms And Strengths
- 20 mg, white or off-white, round, uncoated tablets imprinted with BI logo on one side and 50 H on the other side
- 40 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 51 H on the other side
- 80 mg, white or off-white, oblong, uncoated tablets imprinted with BI logo on one side and 52 H on the other side
Storage And Handling
Telmisartan (Telma AMH) is available as white or off-white, uncoated tablets containing Telmisartan (Telma AMH) 20 mg, 40 mg, or 80 mg. Tablets are marked with the BOEHRINGER INGELHEIM logo on one side, and on the other side, with either 50H, 51H, or 52H for the 20 mg, 40 mg, and 80 mg strengths, respectively. Tablets are provided as follows:
Telmisartan (Telma AMH) tablets 20 mg are round and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0039-37).
Telmisartan (Telma AMH) tablets 40 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0040-37).
Telmisartan (Telma AMH) tablets 80 mg are oblong shaped and individually blister-sealed in cartons of 30 tablets as 3 x 10 cards (NDC 0597-0041-37).
Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Tablets should not be removed from blisters until immediately before administration.
Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA. Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany. Revised: December 2014
See also:
What is the most important information I should know about Amlodipine (Telma AMH)?
Before taking Amlodipine (Telma AMH), tell your doctor if you have congestive heart failure or liver disease.
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Amlodipine (Telma AMH).
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Amlodipine (Telma AMH) is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.
Tell your doctor about all other heart or blood pressure medications you are taking.
Your chest pain may become worse when you first start taking Amlodipine (Telma AMH) or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.
See also:
What is the most important information I should know about Hydrochlorothiazide (Telma AMH)?
You should not use this medication if you are allergic to Hydrochlorothiazide (Telma AMH) or if you are unable to urinate.
Before using this medication, tell your doctor if you have liver disease, kidney disease, glaucoma, asthma or allergies, gout, diabetes, or if you are allergic to sulfa drugs or penicillin.
Avoid drinking alcohol, which can increase some of the side effects of Hydrochlorothiazide (Telma AMH).
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
There are many other drugs that can interact with Hydrochlorothiazide (Telma AMH). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.
See also:
What is the most important information I should know about Telmisartan (Telma AMH)?
Hypersensitivity to Telmisartan (Telma AMH) or to any of the excipients of Telmisartan (Telma AMH).
Biliary obstructive disorders and severe hepatic impairment.
The concomitant use with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m2).
In case of rare hereditary conditions that may be incompatible with an excipient of Telmisartan (Telma AMH), the use of Telmisartan (Telma AMH) is contraindicated.
Use in pregnancy: The use of angiotensin II receptor antagonists is not recommended during the 1st trimester of pregnancy and should not be initiated during pregnancy.
Nonclinical studies with Telmisartan (Telma AMH) do not indicate teratogenic effect, but have shown fetotoxicity.
Angiotensin II receptor antagonist exposure during the 2nd and 3rd trimester is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia).
Unless continued and angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonist should be stopped immediately and if appropriate, alternative therapy should be started.
Should exposure to angiotensin II receptor antagonists have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Infants whose mothers have taken angiotensin II receptor antagonist should be closely observed for hypotension.
Use in lactation: Telmisartan (Telma AMH) is contraindicated during lactation since it is not known whether it is excreted in human milk.
Animal studies have shown excretion of Telmisartan (Telma AMH) in breast milk.
Use Amlodipine (Telma AMH) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Amlodipine (Telma AMH). Talk to your pharmacist if you have questions about this information.
- Take Amlodipine (Telma AMH) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Taking Amlodipine (Telma AMH) at the same time each day will help you remember to take it.
- Continue to take Amlodipine (Telma AMH) even if you feel well. Do not miss any doses.
- If you miss a dose of Amlodipine (Telma AMH), take it as soon as possible. If it has been more than 12 hours since you missed your last dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Amlodipine (Telma AMH).
Use Hydrochlorothiazide (Telma AMH) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Hydrochlorothiazide (Telma AMH) by mouth with or without food.
- If you take colestipol or cholestyramine for high cholesterol, ask your doctor or pharmacist how to take it with Hydrochlorothiazide (Telma AMH).
- Hydrochlorothiazide (Telma AMH) may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- If you miss a dose of Hydrochlorothiazide (Telma AMH), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Hydrochlorothiazide (Telma AMH).
Use Telmisartan (Telma AMH) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Telmisartan (Telma AMH). Talk to your pharmacist if you have questions about this information.
- Take Telmisartan (Telma AMH) by mouth with or without food.
- Do not remove the tablet from the blister seal until you are ready to take your dose.
- Take Telmisartan (Telma AMH) on a regular schedule to get the most benefit from it. Taking Telmisartan (Telma AMH) at the same time each day will help you remember to take it.
- Continue to take Telmisartan (Telma AMH) even if you feel well. Do not miss any doses.
- If you miss a dose of Telmisartan (Telma AMH), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Telmisartan (Telma AMH).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used along with other treatment for certain blood vessel diseases (e.g., arteriosclerosis obliterans, Raynaud's disease, Buerger's disease, cerebrovascular insufficiency). It works by widening blood vessels to help increase blood flow (improve circulation) to certain parts of the body (e.g., hands/feet, brain). This effect may help to decrease symptoms such as cold hands and feet, numbness, tingling, and decreased memory or judgment.
How to use Amlodipine (Telma AMH)
This medication is taken by mouth with or without food, usually 3 to 4 times daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Tell your doctor if your condition persists or worsens.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Hydrochlorothiazide (Telma AMH) is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra salt and water.
This medication also reduces extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, or kidney disease. This can lessen symptoms such as shortness of breath or swelling in your ankles or feet.
How to use Hydrochlorothiazide (Telma AMH)
Take this medication by mouth as directed by your doctor, usually once daily in the morning with or without food. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.
The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.
Cholestyramine and colestipol can decrease the absorption of Hydrochlorothiazide (Telma AMH). If you are taking either of these drugs, take them at least 4 hours before or after taking Hydrochlorothiazide (Telma AMH).
Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings increase).
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Telmisartan (Telma AMH) belongs to a class of medicines known as angiotensin II receptor blockers. It is used to treat high blood pressure, prevention and treatment of heart attack (myocardial Infarction) and heart failure; when heart is unable to pump sufficient blood. It is also used for kidney failure in patients with diabetes.
See also:
What other drugs will affect Amlodipine (Telma AMH)?
Amlodipine (Telma AMH) has been safely administered with thiazide diuretics, alpha-blockers, beta-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.
In vitro data from studies with human plasma indicate that Amlodipine (Telma AMH) has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).
Simvastatin: Co-administration of multiple doses of 10 mg Amlodipine (Telma AMH) with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Amlodipine (Telma AMH) to 20 mg daily.
Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Amlodipine (Telma AMH) in 20 healthy volunteers had no significant effect on the pharmacokinetics of Amlodipine (Telma AMH). The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Amlodipine (Telma AMH); therefore, administration of Amlodipine (Telma AMH) with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.
CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Amlodipine (Telma AMH) in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Amlodipine (Telma AMH) systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Amlodipine (Telma AMH) systemic exposure (22% increase in area under the concentration versus time curve [AUC]). Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.
Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Amlodipine (Telma AMH) to a greater extent than diltiazem. Amlodipine (Telma AMH) should be used with caution when administered with CYP3A4 inhibitors.
Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Amlodipine (Telma AMH). Close observation of patients is recommended when Amlodipine (Telma AMH) is co-administered with clarithromycin.
CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Amlodipine (Telma AMH). Concomitant use of CYP3A4 inducers (e.g., rifampicin, Hypericum perforatum) may decrease the plasma concentrations of Amlodipine (Telma AMH). Amlodipine (Telma AMH) should be used with caution when administered with CYP3A4 inducers.
In the following studies, there were no significant changes in the pharmacokinetics of either Amlodipine (Telma AMH) or another drug within the study, when co-administered.
Special Studies: Effect of Other Agents on Amlodipine (Telma AMH): Cimetidine: Co-administration of Amlodipine (Telma AMH) with cimetidine did not alter the pharmacokinetics of Amlodipine (Telma AMH).
Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Amlodipine (Telma AMH) had no significant effect on the pharmacokinetics of Amlodipine (Telma AMH).
Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Amlodipine (Telma AMH). When Amlodipine (Telma AMH) and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.
Special Studies: Effect of Amlodipine (Telma AMH) on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Amlodipine (Telma AMH) with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.
Digoxin: Co-administration of Amlodipine (Telma AMH) with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.
Ethanol (Alcohol): Single and multiple 10 mg doses of Amlodipine (Telma AMH) had no significant effect on the pharmacokinetics of ethanol.
Warfarin: Co-administration of Amlodipine (Telma AMH) with warfarin did not change the warfarin prothrombin response time.
Cyclosporin: Pharmacokinetic studies with cyclosporin have demonstrated that Amlodipine (Telma AMH) does not significantly alter the pharmacokinetics of cyclosporin.
Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Amlodipine (Telma AMH). In order to avoid toxicity of tacrolimus, administration of Amlodipine (Telma AMH) in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.
Drug/Laboratory Test Interactions: None known.
See also:
What other drugs will affect Hydrochlorothiazide (Telma AMH)?
DIAMOX®. modifies phenytoin metabolism with increased serum levels of phenytoin. This may increase or enhance the occurrence of osteomalacia in some patients receiving chronic phenytoin therapy. Caution is advised in patients receiving chronic concomitant therapy.
By decreasing the gastrointestinal absorption of primidone, DIAMOX may decrease serum concentrations of primidone and its metabolites, with a consequent possible decrease in anticonvulsant effect. Caution is advised when beginning, discontinuing, or changing the dose of DIAMOX in patients receiving primidone.
Because of possible additive effects with other carbonic anhydrase inhibitors, concomitant use is not advisable.
Hydrochlorothiazide (Telma AMH) may increase the effects of other folic acid antagonists.
Hydrochlorothiazide (Telma AMH) may increase or decrease blood glucose levels. Consideration should be taken in patients being treated with antidiabetic agents.
Hydrochlorothiazide (Telma AMH) decreases urinary excretion of amphetamine and may enhance the magnitude and duration of their effect.
Hydrochlorothiazide (Telma AMH) reduces urinary excretion of quinidine and may enhance its effect.
Hydrochlorothiazide (Telma AMH) may prevent the urinary antiseptic effect of methenamine.
Hydrochlorothiazide (Telma AMH) increases lithium excretion and the lithium may be decreased.
Hydrochlorothiazide (Telma AMH) and sodium bicarbonate used concurrently increases the risk of renal calculus formation.
Hydrochlorothiazide (Telma AMH) may elevate cyclosporine levels.
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What other drugs will affect Telmisartan (Telma AMH)?
Aliskiren: Do not co-administer aliskiren with Telmisartan (Telma AMH) in patients with diabetes. Avoid use of aliskiren with Telmisartan (Telma AMH) in patients with renal impairment (GFR < 60 mL/min).
Digoxin: When Telmisartan (Telma AMH) was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing Telmisartan (Telma AMH) for the purpose of keeping the digoxin level within the therapeutic range.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Telmisartan (Telma AMH). Therefore, monitor serum lithium levels during concomitant use.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Telmisartan (Telma AMH), may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Telmisartan (Telma AMH) and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Telmisartan (Telma AMH) may be attenuated by NSAIDs including selective COX-2 inhibitors.
Ramipril and Ramiprilat: Co-administration of Telmisartan (Telma AMH) 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3-and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4-and 1.5-fold, respectively. In contrast, Cmax and AUC of Telmisartan (Telma AMH) decrease by 31% and 16%, respectively. When co-administering Telmisartan (Telma AMH) and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of Telmisartan (Telma AMH). Concomitant use of Telmisartan (Telma AMH) and ramipril is not recommended.
Other Drugs: Co-administration of Telmisartan (Telma AMH) did not result in a clinically significant interaction with acetaminophen, Telmisartan (Telma AMH), glyburide, simvastatin, Telmisartan (Telma AMH), warfarin, or ibuprofen. Telmisartan (Telma AMH) is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Telmisartan (Telma AMH) is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.
See also:
What are the possible side effects of Amlodipine (Telma AMH)?
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Amlodipine (Telma AMH) has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with Amlodipine (Telma AMH) was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with Amlodipine (Telma AMH) were of mild or moderate severity. In controlled clinical trials directly comparing Amlodipine (Telma AMH) (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of Amlodipine (Telma AMH) because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below. The incidence (%) of side effects that occurred in a dose related manner are as follows:
2.5 mg | Amlodipine (Telma AMH) 5 mg | 10 mg | Placebo | |
N=275 | N=296 | N=268 | N=520 | |
Edema | 1.8 | 3.0 | 10.8 | 0.6 |
Dizziness | 1.1 | 3.4 | 3.4 | 1.5 |
Flushing | 0.7 | 1.4 | 2.6 | 0.0 |
Palpitation | 0.7 | 1.4 | 4.5 | 0.6 |
Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
Amlodipine (Telma AMH) (%) (N=1730) | Placebo (%) (N=1250) | |
Fatigue | 4.5 | 2.8 |
Nausea | 2.9 | 1.9 |
Abdominal Pain | 1.6 | 0.3 |
Somnolence | 1.4 | 0.6 |
For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with Amlodipine (Telma AMH) treatment as shown in the following table:
Amlodipine (Telma AMH) | Placebo | |||
Male=% (N=1218) | Female=% (N=512) | Male=% (N=914) | Female=% (N=336) | |
Edema | 5.6 | 14.6 | 1.4 | 5.1 |
Flushing | 1.5 | 4.5 | 0.3 | 0.9 |
Palpitations | 1.4 | 3.3 | 0.9 | 0.9 |
Somnolence | 1.3 | 1.6 | 0.8 | 0.3 |
The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Cardiovascular
arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.
Central And Peripheral Nervous System
hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
Gastrointestinal
anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General
allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.
Musculoskeletal System
arthralgia, arthrosis, muscle cramps,These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
See also:
What are the possible side effects of Hydrochlorothiazide (Telma AMH)?
Applies to Hydrochlorothiazide (Telma AMH): oral capsule, oral solution, oral tablet
As well as its needed effects, Hydrochlorothiazide (Telma AMH) (the active ingredient contained in Hydrochlorothiazide (Telma AMH)) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Hydrochlorothiazide (Telma AMH), check with your doctor immediately:
Incidence not known:
- Abdominal or stomach pain
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- bloating
- blood in the urine or stools
- bloody urine
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- chills
- clay-colored stools
- cloudy urine
- cold sweats
- confusion
- constipation
- cough or hoarseness
- coughing that sometimes produces a pink frothy sputum
- coughing up blood
- cracks in the skin
- darkened urine
- decrease in urine output or decrease in urine-concentrating ability
- decreased frequency or amount of urine
- diarrhea
- difficult, fast, or noisy breathing, sometimes with wheezing
- difficulty with breathing
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- dry mouth
- fast or irregular heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- general body swelling
- general feeling of discomfort or illness
- general feeling of tiredness or weakness
- greatly decreased frequency of urination or amount of urine
- headache
- hives
- increased blood pressure
- increased hunger
- increased sweating
- increased thirst
- increased urination
- indigestion
- itching
- joint pain, stiffness, or swelling
- loss of appetite
- loss of heat from the body
- lower back or side pain
- muscle cramps or pain
- nausea or vomiting
- nosebleeds
- numbness, tingling, pain, or weakness in the hands or feet
- pain in the joints or muscles
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- red, irritated eyes
- red skin lesions, often with a purple center
- red, swollen skin
- redness, soreness, or itching skin
- scaly skin
- seizures
- shortness of breath
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sores, welting, or blisters
- sugar in the urine
- swelling of the face, fingers, legs, ankles, feet, or lower legs
- swollen or painful glands
- tenderness of salivary glands
- thickening of bronchial secretions
- tightness in the chest
- trembling
- troubled breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight loss
- vomiting of blood
- weakness and heaviness of the legs
- weight gain
- wheezing
- yellow eyes or skin
Minor Side Effects
Some Hydrochlorothiazide (Telma AMH) side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
Incidence not known:
- Cramping
- decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- feeling of constant movement of self or surroundings
- hair loss or thinning of the hair
- inability to have or keep an erection
- increased sensitivity of the skin to sunlight
- loss in sexual ability, desire, drive, or performance
- muscle spasm
- pinpoint red or purple spots on the skin
- redness or other discoloration of the skin
- restlessness
- sensation of spinning
- severe sunburn
- weakness
See also:
What are the possible side effects of Telmisartan (Telma AMH)?
The following adverse reaction is described elsewhere in labeling:
Renal dysfunction upon use with ramipril
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Hypertension
Telmisartan (Telma AMH) has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.
In placebo-controlled trials involving 1041 patients treated with various doses of Telmisartan (Telma AMH) (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.
Adverse events occurring at an incidence of ≥1% in patients treated with Telmisartan (Telma AMH) and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.
Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with Telmisartan (Telma AMH) and at a Greater Rate Than Patients Treated with Placebo
In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with Telmisartan (Telma AMH) tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.
The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.
The incidence of cough occurring with Telmisartan (Telma AMH) in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).
In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with Telmisartan (Telma AMH) monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Telmisartan (Telma AMH) tablets:
Autonomic Nervous System: impotence, increased sweating, flushing; Body as a Whole: allergy, fever, leg pain, malaise; Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia; Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic: gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal: arthritis, arthralgia, leg cramps; Psychiatric: anxiety, depression, nervousness; Resistance Mechanism: infection, fungal infection, abscess, otitis media; Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis; Vascular: cerebrovascular disorder; and Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.
During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).
Clinical Laboratory Findings
In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Telmisartan (Telma AMH) tablets.
Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Telmisartan (Telma AMH) patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.
Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Telmisartan (Telma AMH) patients compared with 0.3% placebo patients. One Telmisartan (Telma AMH)-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.
Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with Telmisartan (Telma AMH); all marked elevations occurred at a higher frequency with placebo. No Telmisartan (Telma AMH)-treated patients discontinued therapy because of abnormal hepatic function.
Cardiovascular Risk Reduction
Because common adverse reactions were well characterized in studies of Telmisartan (Telma AMH) in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Telmisartan (Telma AMH) for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on Telmisartan (Telma AMH) and 7.6% on placebo. The only serious adverse events at least 1% more common on Telmisartan (Telma AMH) than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Telmisartan (Telma AMH). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Telmisartan (Telma AMH).
The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including Telmisartan (Telma AMH).